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Operon Strategist Medical Device Design and Development Review

4

·

Very good

Revainrating 4.5 out of 5  
Rating 
4.5
Other Services, Health Services

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Description of Operon Strategist Medical Device Design and Development

Operon Strategist is the medical device and regulatory consulting providing services to medical device and primary packaging material manufacturers. We assist manufacturers with complete turkey project which includes manufacturing plant layout design, QMS certification for their product and we also help them in Design and Development of the medical device, combination products, etc. ISO 13485, ISO 15378, CDSCO, FDA, CE Marking, FDA 21 CFR Part 820, FDA 21 CRF Part 210 and 211, FDA 21 CFR Part 820.30, CAPA Management.

Reviews

Global ratings 4
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Type of review

Revainrating 4 out of 5

Great resource in helping me find solutions

I liked the fact that they are always on the ball and very responsive. They are always willing to help even after hours if needed. They are very detail oriented and always do a good job. It's good to have a company like this that can help out with the details. I don't like that they sometimes seem to be slow to respond. If I had to choose one thing, I think that getting a quote is a bit difficult. They have a bit of a learning curve. We have a very specific needs that the product we're using…

Pros
  • Very knowledgeable people who really enjoy their work; dedicated team members ready/willing to go above & beyond expectations in order meet client requirements excellent communicators!!!!! :) highly recommended!!!!
Cons
  • Nothing much..just wish there was more frequent updates from our engineers

Revainrating 5 out of 5

Excellent Customer Service & Manufacturing Engineering Consulting

I have worked with this organization twice and each time was a learning experience. Each person I've come in contact with has been wonderful and helpful. So far I love everything about this company. I would highly recommend anyone considering their manufacturing engineering to go for it. My personal projects have been successful working with Operon. They are extremely knowledgeable and are very open with you when giving their opinion of any situation. Their knowledge of the manufacturing side

Pros
  • High level expertise, understanding how best things should happen within medical device world / business structure..etc
Cons
  • Mostly okay, but...

Revainrating 4 out of 5

Excellent support, strategic consultation and advisory services

The team at operons has been very helpful from beginning stages through final approval by USPTO/CE marks as well as pre-launch marketing strategy development (including social media). They are diligent about keeping us informed throughout each stage - sometimes that's what you need! I would highly recommend working collaboratively wtih this firm if your market requires extensive attention or resources during early phases before launch; they will be there every step along way helping guide…

Pros
  • Great to work wth for long term projects requiring frequent communication
Cons
  • no negatives found so far in relation

Revainrating 5 out of 5

User friendly cloud-based ERP Solution for Health Care Industry

The team at operons are very helpful as they have vast knowledge about all sectors related like health care industry specifically devices domain so it's easy working out queries from my side alongwith quick response time too! I would say nothing much apart form great customer service but then again that part could be improved upon further by giving more benefits packages i guess!! Good experience while using this software though not sure if any other similar softwares can beat its…